The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval Undergoing Cesarean Section

Last updated: February 5, 2024
Sponsor: Ataturk University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Treatment

BMI:18,5-24,9; Combined Spinal Epidural Anesthesia

BMI≥30; Combined Spinal Epidural Anesthesia

Clinical Study ID

NCT06018805
B.30.2.ATA.0.01.00/408
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

Cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. Cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section.

The most important side effects of spinal anaesthesia are problems such as hypotension, bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary retention.

Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the epidural block is administered alone. The administration of spinal anaesthesia alone causes changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may decrease by 5-20% during spinal anaesthesia.

Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and mortality have increased. In addition, supine hypotension syndrome is a common problem in obese pregnant women. The aim of this study is to compare the change in QTc interval in obese and non-obese term pregnancies planned for elective cesarean section with combined spinal epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac pathologies during and after surgery in obese pregnant women.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with BMI≥30 and BMI values between 18.5 and 24.9.

Exclusion

Exclusion Criteria:

  • allergic to the drugs used in the study,
  • who do not accept regional anesthesia,
  • body mass index did not meet the inclusion criteria in the study,
  • under 150 cm in height,
  • who received treatment other than perinatal iron and vitamin drugs,
  • smoking or drinking alcohol,
  • with a known fetal anomaly,
  • with placental disorders such as placenta previa,
  • with multiple pregnancy
  • have renal or liver disease,
  • diagnosed with hypertension or preeclampsia,
  • uncooperative and previously treated or currently receiving treatment for apsychiatric disorder
  • Mothers who do not want to participate in the study will not be included in the study.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Ataturk University

    Erzurum, 25100
    Turkey

    Active - Recruiting

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